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New recommendations on Sodium Valproate



European Medicines Agency releases new recommendations on Sodium Valproate to better support women with epilepsy

Following from last years’ hearing into Sodium Valproate, the European Medicines Agency have today (9 February) released new recommendations on changes needed to better inform women of the risks linked to the medication on unborn children.

  • They recommend women taking Valproate for their epilepsy should swap to an alternate medication, unless Valproate is the best choice for them to control their seizures
  • For women who need to keep taking Valproate, a new programme has been created to support clinicians and women with epilepsy to regularly discuss and monitor their treatment; which includes improved pre-conception counselling and regular reviews

We hope this programme will also make sure women taking Valproate, get balanced risk messages about wider epilepsy risks (inlcuding those linked to SUDEP), to help them make informed choices about how to reduce their own risks, as well as those to their baby. This is something we reported into the public hearing and the importance of which is shown by the 2017 MBRRACE report into maternal epilepsy deaths.

“It is important that all women with epilepsy are aware of how to reduce their risks, not just those taking Sodium Valproate; so that they can work with their clinicians to reduce risk before, during and after pregnancy. This is why talking about pregnancy and contraception is a key part of our SUDEP and Seizure Safety Checklist; to help support these vital discussions, which can lead to actions being taken that can help keep both mum and baby safe.” Sammy Ashby – Director of Policy & Development, and PPI Lead for the SUDEP & Seizure Safety Checklist & EpSMon

For more information on how to reduce epilepsy risks, visit our Epilepsy and Risk section; including the latest risk information, developed from the SUDEP and Seizure Safety Checklist and the research which supports the tool. People with epilepsy may also benefit from using EpSMon, a free award-winning app to help them monitor and manage their condition in between appointments. The app uses information from the Checklist and is supported by the NHS Innovation Accelerator Programme.

The SUDEP & Seizure Safety Checklist is a free, award-winning tool which supports clinicians in discussing key risk factors linked to epilepsy mortality, including SUDEP, with their patients so actions can be taken to manage risk. The tool is used by over 440 clinicians, in various health settings nationwide and is supported by a Development Group of 21 leading UK experts, including Kim Morley (Epilepsy Specialist Midwife).